Trim-to-fit therapeutic compression garment system and method

ABSTRACT

A method of treating a condition of a patient&#39;s limb is disclosed. The method may use a compression garment wrappable about the limb and a template comprising markings showing where to trim the compression garment to fit a smaller size limb. Measurements may be taken of a circumference of the limb of the patient. Next, the template may be positioned to overlay at least a portion of the compression garment. The compression garment may then be cut or trimmed proximate a marking of the markings matching the measurement.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/169,240 filed Jun. 27, 2011, which: (1) claims the benefit of U.S.Provisional Patent Application Ser. No. 61/478,515 filed Apr. 24, 2011;(2) is a continuation-in-part of co-pending U.S. patent application Ser.No. 12/391,051 filed Feb. 23, 2009, which claims the benefit of U.S.Provisional Patent Application Ser. No. 61/092,459 filed Aug. 28, 2008;and (3) is a continuation-in-part of co-pending U.S. patent applicationSer. No. 12/796,579 filed Jun. 8, 2010, which claims the benefit of U.S.Provisional Patent Application Ser. No. 61/185,129 filed Jun. 8, 2009.U.S. patent application Ser. No. 13/169,240 is hereby incorporated byreference.

BACKGROUND

1. the Field of the Invention

This disclosure relates to apparatus, methods, and systems for treatingmedical conditions by application of controlled compression to generaland specific areas of a human or animal body.

2. The Background Art

Excessive interstitial fluid accumulation, referred to as edema, mayarise from a variety of illnesses and conditions, including venousvalvular insufficiency, postphlebotic syndrome, and lymphedema.Compression methods and systems control edema by reducing interstitialfluid. This in turn may increase nutrient delivery to tissues, removewaste from tissues, relieve pain from swelling, increase tissueoxygenation and promote wound healing, and decrease risk of infection.However, typical compression technologies have certain drawbacks.

For example, due to considerable variation in limb shapes and sizes,custom garments may typically be required. However, typical customgarments take time to manufacture. A delay of about one month is notuncommon between the time an order for a custom garment is placed andthe time the custom garment is received by the patient. Furthermore,errors in manufacturing and measurement sometimes necessitateremanufacture of the garment or alteration of the garment to obtain aproper fit. This is very inconvenient for the patient, who needstherapeutic compression immediately and must make-do with anoff-the-shelf garment or bandage until a proper custom garment can bereceived and utilized.

In view of the foregoing, what is needed is an improved compressiongarment that can be quickly and easily fit to a patient.

BRIEF SUMMARY OF THE INVENTION

In accordance with aspects of the present invention, an apparatus andmethod for facilitating therapeutic compression is presented. Theapparatus and method may provide controlled and repeatable baselinecompressions with intuitive feedback to patients. The feedback mayenable a patient to safely apply proper compression, and propercompression profiles or gradients, without the need for frequent visitsto clinics for trained practitioner services.

In selected embodiments, a therapeutic system in accordance with thepresent invention may include a compression garment coupled to one ormore markings. The markings may enabling a user to alter (e.g., cut ortrim) a compression garment in a manner ensuring that the desiredcompression profile is delivered to a patient. In general, it may berelatively expensive, time consuming, or both to apply markings directlyonto a compression garment. Accordingly, in certain embodiments, atherapeutic system in accordance with the present invention may includeone or more templates having the markings.

A template may enable someone to alter a compression garment without theexpense and time consumption typically associated with marking directlyonto a compression garment. A template may do this in one of at leasttwo ways. In certain embodiments, a template may be formed of aninexpensive, disposable substrate upon which markings may easily beapplied. For example, a template may comprise paper or plastic. Paperand plastic may each form an inexpensive, disposable substrate.Moreover, printing markings on paper or plastic may be comparativelyquick and inexpensive. Alternatively, a template may be formed of a moreexpensive, reusable substrate whose cost may be distributed acrossmultiple compression garments.

A method in accordance with the present invention may supportcustomization of a compression garment to properly fit a particularpatient. The method may include taking one or more measurements from alimb (e.g., foot, leg, hand, arm, etc.) of a patient. The method mayfurther include obtaining a compression garment and obtaining atemplate. Obtaining a template may comprise selecting a proper templatefrom among several templates packaged and distributed with thecompression garment. The several templates may include differenttemplates accommodating or addressing different limb lengths, limbcircumferences, limb geometries or shapes, compression levels,compression profiles, or the like or combinations thereof.

Once it is obtained or selected, a template may be applied to acompression garment in any suitable manner. In selected embodiments,application of a template to a compression garment may include spreadingthe compression garment out flat on a surface and then overlaying thecompression garment with the template. In certain embodiments, acompression garment and a template 14 may have one or more correspondingor matching fiducials enabling a user to properly position the template14 with respect to the compression garment.

Once a proper alignment between a template and a compression garment hasbeen achieved, a user may use the template to identify one or morelocations to cut or trim the compression garment. The user may then cutthe compression garment at such locations. With the cutting complete,the now customized compression garment may be donned by the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing features of the present invention will become more fullyapparent from the following description and appended claims, taken inconjunction with the accompanying drawings. Understanding that thesedrawings depict only typical embodiments of the invention and are,therefore, not to be considered limiting of its scope, the inventionwill be described with additional specificity and detail through use ofthe accompanying drawings in which:

FIG. 1 is a schematic block diagram illustrating one embodiment of atherapeutic system in accordance with the present invention;

FIG. 2 is an illustration showing a non-exhaustive list of compressiongarments that may be used in a therapeutic system in accordance with thepresent invention;

FIG. 3 is a schematic block diagram of one embodiment of a distributionmethod in accordance with the present invention;

FIG. 4 is a schematic block diagram of one embodiment of a customizationmethod in accordance with the present invention;

FIG. 5 is an illustration showing one embodiment of a worksheet inaccordance with the present invention for recording measurements of apatient's arm;

FIG. 6 is an illustration showing one embodiment of a worksheet inaccordance with the present invention for recording measurements of apatient's lower leg;

FIG. 7 is an illustration showing one embodiment of a worksheet inaccordance with the present invention for recording measurements of apatient's leg;

FIG. 8 is a plan view of one embodiment of a template in accordance withthe present invention for customizing a compression garment for thelower leg and foot of a patient;

FIG. 9 is a plan view of one embodiment of a template in accordance withthe present invention for customizing a compression garment for the armof a patient;

FIG. 10 is a plan view of one embodiment of a template in accordancewith the present invention for customizing a compression garment for thefoot of a patient;

FIG. 11 is a plan view of one embodiment of a template in accordancewith the present invention for customizing a multi-band compressiongarment for the lower leg of a patient;

FIG. 12 is a plan view of an alternative embodiment of a template inaccordance with the present invention overlaying a compression garment(shown with dashed lines) for the lower leg of a patient;

FIG. 13 is a plan view of another alternative embodiment of a templatein accordance with the present invention for customizing a compressiongarment for the lower leg of a patient; and

FIG. 14 is a plan view of another alternative embodiment of a templatein accordance with the present invention for customizing a compressiongarment for the lower leg of a patient, the template having the sameexterior border as the template of FIG. 13 but with different markingsto accommodate a different sized patient, a different compression level,or the like or some combination thereof.

DETAILED DESCRIPTION OF SELECTED EMBODIMENTS

It will be readily understood that the components of the presentinvention, as generally described and illustrated in the drawingsherein, could be arranged and designed in a wide variety of differentconfigurations. Thus, the following more detailed description of theembodiments of the system and method of the present invention, asrepresented in the drawings, is not intended to limit the scope of theinvention, as claimed, but is merely representative of variousembodiments of the invention. The illustrated embodiments of theinvention will be best understood by reference to the drawings, whereinlike parts are designated by like numerals throughout.

Referring to FIG. 1, a therapeutic system 10 in accordance with thepresent invention may include a compression garment 12 coupled to one ormore templates 14. A compression garment 12 may be constructed todeliver a desired compression profile to a patient. A template 14 maycomprise a substrate for communicating (e.g., receiving and displaying)one or more markings 16 (e.g., lines 16, curves 16, slots 16, numbers16, indicia 16, fiducials 16, text 16, or the like, or combinationsthereof). Such markings 16 may enable a user (e.g., the patient,healthcare personnel, etc.) to alter the compression garment 12 in amanner ensuring that the desired compression profile is delivered to thepatient. In selected embodiments, a template 14 may include markings 16indicating where a compression garment 12 may be cut or trimmed toprovide a desired compression profile to a particular patient.

Referring to FIG. 2, a compression garment 12 in accordance with thepresent invention may have any suitable configuration, construction, orcombination thereof. Various compression garment features, materials,fabrics, physical properties, combinations, methods, bands, attachmentmechanisms or closures, liners, padding, shapes, dimensions, and thelike are disclosed in U.S. Patent App. Publication No. 2005/0209545 A1,U.S. Patent App. Publication No. 2007/0179421 A1, U.S. Patent App.Publication No. 2010/0056973 A1, and U.S. Patent App. Publication No.2010/0312160 A1, each of which is hereby incorporated by reference. Anysuitable embodiment, sub-combination of an embodiment, combination ofembodiments, and the like of such garments, features, materials,methods, etc. may be used to produce a compression garment 12, template14, instruction sheet, worksheet, method, or the like in accordance withthe present invention.

Referring to FIG. 3, one method 18 in accordance with the presentinvention may support distribution of a therapeutic system 10. Themethod 18 may include obtaining 20 a compression garment 12. Acompression garment 12 may be obtained 20 in any suitable manner. Inselected embodiments, a compression garment 12 may be manufactured by anentity executing the method 18. In other embodiments, the entityexecuting the method 18 may obtain 20 the compression garment 12 fromsome other entity or source.

In selected embodiments, when a compression garment 12 is obtained 20,it may be in a substantially completely manufactured form. For example,the compression garment 12 may be obtained 20 in such a form that it maybe immediately and properly donned by at least some person. However,since a particular patient may not be shaped like that person, thecompression garment 12 may be obtained 20 in a form requiring sometailoring to properly fit that particular patient. Notwithstanding suchtailoring, the compression garment 12 in such embodiments may beconsidered substantially completely manufactured.

In other embodiments, a compression garment 12 may be obtained 20 in apartially manufactured form. That is, some, but not all, manufacturingprocesses necessary to produce the final compression garment 12 may havebeen completed. For example, the compression garment 12 may be obtained20 in such a form that it cannot be immediately and properly donned byanyone. In such embodiments, additional work on the compression garment12 would be require before it could be donned by any patient or source.

The method 18 may also include obtaining 22 one or more templates 14. Atemplate 14 may be obtained in any suitable manner. In selectedembodiments, a template 14 may be manufactured by an entity executingthe method 18. In other embodiments, the entity executing the method mayobtain 22 the template 14 from some other entity.

In general, it may be relatively expensive, time consuming, or both toapply (e.g., embroider, print, etc.) markings 16 directly onto acompression garment 12. A template 14 may enable someone to alter acompression garment 12 without that expensive or time consuming process.This may be done in one of at least two ways. In certain embodiments, atemplate 14 may be formed of an inexpensive, disposable substrate uponwhich markings 16 may easily be applied. For example, a template 14 maycomprise paper or plastic. Paper and plastic may each form aninexpensive, disposable substrate. Moreover, printing markings 16 onpaper or plastic may be comparatively quick and inexpensive.

Alternatively, a template 14 may be formed of a more expensive, reusablesubstrate whose cost may be distributed across multiple compressiongarments 12. A reusable template 14 may be flexible or rigid. Forexample, a template 14 may comprise cardboard, laminated material,polymer material, metal, or the like. Such a template 14 may be used totrim or cut multiple compression garments 12. In selected embodiments, atemplate 14 may include various slots formed therein. When such atemplate 12 is applied to a compression garment 12, one or more slots oredges may guide a cutting tool (e.g., roller knife or cutting blade)traveling therealong or therewithin along a particular path to providethe desired alteration to the compression garment 12. Accordingly, thetemplate 14 itself may not be altered during use and may be applied tomultiple compression garments 12.

A template 14 may form a single piece. For example, a template 14 may beformed from a single sheet of paper or plastic. Alternatively, atemplate 14 may be precut or preassembled from one or more pieces. Forexample, a template 14 may comprise multiple, overlapping pieces ofpaper, plastic, or the like.

Once the compression garment 12 and the one or more templates 14 havebeen obtained 20, 22, they may be distributed 24 together. For example,a substantially completely manufactured or partially manufacturedcompression garment 12 may be packed with one or more templates 14 andshipped to a patient, health care provider, medical supply company, orthe like. In certain shipments or packages (e.g., shipments or packagescomprising exclusively disposable templates 14), the ratio of templates14 to compression garments 12 may be greater than or equal to one. Inother shipments or packages (e.g., shipments or packages comprisingexclusively reusable templates 14), the ratio of templates 14 tocompression garments 12 may be less then one.

In selected embodiments, a compression garment 12 may distributed 24with a “soft copy” of a template 14. A soft copy may comprise a digitalfile (e.g, PDF file, JPEG file, or the like) that may be viewed,projected, printed, plotted, or the like to support the desiredalteration to the compression garment 12. A soft copy of a template 14may be stored on a non-transitory, computer-readable medium (e.g., CDROM) distributed 24 with a compression garment 12. Alternatively, acompression garment 12 may be distributed 24 with information linking acompression garment 12 to a soft copy of a template 14. For example, acompression garment 12 may be distributed 24 with an address (e.g.,Internet address, email address) from which the soft copy, customizationinstructions, a customization demonstration, or some combination thereofmay be obtained (e.g., requested, viewed, downloaded, printed, etc.) bya user.

Referring to FIGS. 4-7, one method 26 in accordance with the presentinvention may support customization (e.g., on-site or on-demandcustomization) of a compression garment 12 to properly fit a particularpatient. The method 26 may include taking 28 one or more measurementsfrom a limb (e.g., foot, leg, hand, arm, etc.) of a patient.Accordingly, in selected embodiments, a compression garment 12 may belinked to, accompanied by, or distributed 24 with materials (e.g.,instructions) assisting a user in taking 28 the necessary measurements.

For example, a compression garment 12 may be linked to, accompanied by,or distributed 24 with a worksheet 30. A worksheet 30 may inform a userhow and where to take 28 measures, given the nature of the correspondingcompression garment 12 or garments 12. Different worksheets 30 maycorrespond to different compression garments 12. For example, oneworksheet 30 a may correspond to a compression garment 12 for an arm,another worksheet 30 b may correspond to a compression garment 12 for alower leg, another worksheet 30 c may correspond to a compressiongarment 12 for an entire leg, etc. A worksheet 30 may provide locations32 for a user to record the measurements taken 28. In selectedembodiments, a worksheet 30 may guide a user in selecting which template14 to use to properly customize the compression garment 12.

A customization method 26 in accordance with the present invention mayfurther include obtaining 34 a compression garment 12 and obtaining 36 atemplate 14. In selected embodiments, obtaining 36 a template 14 maycomprise selecting a proper template 14 from among several templates 14(e.g., from among several templates 14 packaged and distributed 24 withthe compression garment 12). The several templates 14 may includedifferent templates 14 accommodating or addressing different limblengths, limb circumferences, limb geometries or shapes (e.g., very widecalf muscles, large skin lobules, etc.), compression levels, compressionprofiles, or the like.

When selecting a template 14 from among several templates 14, eachtemplate 14 of the several need not be universally applicable. Forexample, each template 14 does not need to have markings 16 pertainingto every potential modification of a corresponding compression garment12. Rather, each template 14 may comprise markings 16 corresponding to alimited set of potential modification. Accordingly, no template 14 needsto have an excessive or confusing quantity or arrangement of markings16. Collectively, however, the several templates 14 may support all or asignificant portion of desired modifications to the correspondingcompression garment 12.

In selected embodiments, the several templates 14 may constitute anarray of sizes (e.g., extra small, small, medium, large, extra large,extra extra large, or some combination thereof). In such embodiments, atemplate 14 corresponding to a particular size may focus on a limitedset of modifications surrounding that particular size. For example, anextra small template 14 may provide an array of markings 16 fortailoring a compression garment 12 to a patient limb that may becharacterized as extra small. Conversely, an extra large template 14 mayprovide an array of markings 16 for tailoring a compression garment 12to a patient limb that may be characterized as extra large.

Alternatively, or in addition thereto, the several templates 12 maysupport customization of a compression garment 12 to provide differentlevels of compression. For example, one template 14 may correspond to agarment 12 applied at about 100% stretch (e.g., substantially at endstretch, maximal stretch, or near the end of its elastic range), whileone or more other templates 14 may correspond to a garment 12 applied atless than 100% stretch (e.g., 75% stretch, 50% stretch, or the like). Atemplate 14 may also enable or support creation of a compression garment12 to be applied with more stretch in some areas and less in others. Forexample, a template 14 may enable or guide a user to customize acompression garment 12 so that it is applied at 75% stretch around ajoint area for better comfort, but applied at 90-100% stretch around acalf muscle for better calf muscle pump activation.

In selected embodiments, one template 14 may tailor a compressiongarment 12 to provide compression of about 20-30 mm Hg. Another template14 may tailor a compression garment 12 to provide compression of about30-40 mm Hg. One or more templates 14 may enable a user to tailor acompression garment 12 to any of the standard compression levels used inthe United States (e.g., 8-15 mm Hg, 15-20 mm Hg, 20-30 mm Hg, 30-40 mmHg, 40-50 mm Hg, or higher). One or more templates 14 may enable a userto tailor a compression garment 12 to any other standard compressionlevels (e.g., compression levels associated with the German RaulStandard, United Kingdom standard, French standard, or the like).

Through the use of templates 14, the number of compression garments 12stocked by an entity (e.g., clinic, hospital, supplier or distributor ofdurable medical equipment (DME), or the like) may be significantlyreduced. The entity may stock a particular compression garment 12 thatmay be trimmed to various sizes. Accordingly, the entity need not stockmultiple sizes of the particular compression garment. Moreover, byobtaining 36 (e.g., selecting) a proper template 14, the markings 16provided thereby may be simplified and focused so as not to confuse auser.

There may be some reluctance of a user to trim a compression garment 12.This reluctance may be based on a fear that the user will not cut thecompression garment 12 properly, thereby wasting the compression garment12 and the money spent thereon. Accordingly, in selected embodiments,once a template 14 has been obtained 36, it may be trimmed 38. A trimmedtemplate 14 may be applied to the corresponding limb, thereby providinga proof of the process and the measurements taken 28. In selectedembodiments, a template 14 may have one or more regions having a stickybacking enabling the template 14 to be placed around a patient's limband stay there for sizing verification. After which, the template 14 maybe removed from the limb.

By trimming 38 a template 14, a user may feel more comfortable trimmingthe actual compression garment 12 and lower the risk of trimming itincorrectly. In selected embodiments, a compression garment 12 may bedistributed 24 with multiple copies of the same template 14.Accordingly, should a user trim 38 one such template 14 incorrectly, awhole template 14 may still be available for use.

A template 14 may be applied 40 to a compression garment 12 in anysuitable manner. The manner of application 40 may depend on thecharacteristics of the compression garment 12, the template 14, or both.In selected embodiments, application 40 of a template 14 to acompression garment 12 may include spreading the compression garment 12out flat on a surface and then overlaying the compression garment 12with the template 14.

In certain embodiments, a compression garment 12 and a template 14 mayhave one or more corresponding or matching fiducials. A fiducial maycomprise a location reference. Matching (e.g., overlaying) fiducialsbetween a compression garment 12 and a corresponding template 14 mayenable a user to properly position the template 14 with respect to thecompression garment 12. Suitable fiducials may include seams, points,lines, curves, boundaries, edges, labels, notches, and the like.

For example, in selected embodiments, the shape (or some portionthereof) of a template 14 may match the shape or boundary profile of acompression garment 12. Accordingly, alignment of one or more edges on atemplate 14 with corresponding edges on a compression garment 12 mayensure that the two components 12, 14 are properly aligned with respectto one another.

A template 14 may be transparent, semi-transparent, or opaque. Inselected embodiments, a template 14 that is transparent orsemi-transparent may enable a user to more easily orient a template 14properly with respect to a compression garment 12 (e.g., align afiducial on a template 14 with a corresponding fiducial on a compressiongarment 12). Alternatively, or in addition thereto, a template 14 mayinclude one or more regions configured to adhere to at least a certaindegree to a compression garment 12. Such regions may resist relativemovement between a template 14 and a compression garment 12 duringcustomization (e.g., trimming) of the compression garment 12. Inselected embodiments, a template 14 may be backed with a stickymaterial. In other embodiments, a template 14 may be statically charged,include one or more regions of hook-and-loop type material (e.g., thehook portion of such material), or the like to provide a desiredadhesion.

In certain embodiments, a customization method 26 in accordance with thepresent invention may be performed at a particular location (e.g.,clinic, hospital, place of business of a supplier or distributor of DME,or the like) with sufficient frequency to merit selected structuresfacilitating that method 26. Such locations may be consideredcustomization sites. Reusable templates 14 may be well suited for use ata customization site. Alternatively, or in addition thereto, acustomization site may include a computer programmed to receive themeasurements taken 28 from a patient and output or identify anappropriate template 14. In selected embodiments, the appropriatetemplate 14 may be output in a printing process (e.g., printing orplotting on a substrate such as paper, plastic, or the like). In certainembodiments, the appropriate template 14 may be printed or plotteddirectly onto a corresponding compression garment 12.

Alternatively, the appropriate template 14 may be output (e.g., applied40 to a compression garment 12) in exclusively a visual manner. Forexample, a template 14 may be projected onto a compression garment 12.This may be accomplished using a digital projector (e.g., videoprojector) or an overhead projector, a computer display screen ormonitor, or the like. A user may move the compression garment 12 untilit is properly aligned with the projected template 14. For example, auser may move the compression garment 12 until one or more fiducials onthe compression garment 14 align corresponding fiducials on theprojected template 14.

Once a proper alignment between a template 14 and a compression garment12 has been achieved, a user may use 42 the template 14 to identify oneor more locations to cut or trim the compression garment 12. The usermay then cut 44 the compression garment 12 at such locations. With thecutting 44 complete, the now customized compression garment 12 may beapplied 46 to a corresponding patient (e.g., donned by the correspondingpatient). In selected situations or applications, a customization method26 in accordance with the present invention may be applied more thanonce to a particular compression garment 12 or for a particular patient.For example, following a period of successful compression treatment, theedema within a limb may be reduced. Accordingly the dimensions or shapeof the limb may have changed since a first application of the method 26.The effectiveness of the compression garment 12 may be reduced. Thus,the method 26 may be repeated to customize the compression garment 12 tothe new (e.g., reduced) dimensions, shape, or the like of the patient.In certain embodiments, a disposable (e.g., paper) template 14 used inthe first application of the method 26 may be used in one or moresubsequent applications of the method 26.

Referring to FIG. 8, in selected embodiments, a template 14 may have a“fishbone” type design comprising a central spine 48 and multiplebranches 50 extending from either side thereof. The various sections orportions of the template 14 may correspond to different portions of alimb. For example, a first portion 52 may correspond to a lower leg, asecond portion 54 may correspond to a heel, and a third portion 56 maycorrespond to a foot. Such a template 14 may be well suited for use witha compression garment 12 comprising overlapping bands. Markings 16 onthe ends of the various branches 50 may identify various locations wherethe bands may be cut or trimmed.

Referring to FIGS. 9-14, templates 14 in accordance with the presentinvention may include markings 16 of various kinds. For example,templates 14 may include textual (e.g., number) markings 16 a, cut ortrim lines 16 b (e.g., lines identifying where to cut or trim acorresponding compression garment 12), fiducials 16 c (e.g., edges 16 cand markings 16 c or text 16 c showing where to positioning a template14 or corresponding garment 12 on a patient), dividing lines 16 d (e.g.,lines identifying where to make certain dividing or partial dividingcuts), hash marks 16 e (e.g., markings communicating incrementaldistances), and the like.

In selected embodiments, textual markings 16 a may correspond tomeasurements taken 28 from a patient. Accordingly, if a particularcircumference taken 28 from a patient has a certain value (e.g., 20 cm),then the user may cut 44 or trim 44 a corresponding portion of acorresponding compression garment 12 along a line 16 b associated with a“20” textual marking 16 a. Should a measured value fall between twotextual markings 16 a, the user may be instructed to use (e.g., cutalong the line 16 b corresponding to) the higher value of the two.Alternatively, the user may be instructed to make approximations (e.g.,trim between the lines 16 b or other fiducial markings 16 c).

Fiducials 16 c and other markings 16 may be used to align a compressiongarment 12 to anatomical landmarks on a patient. They may also be usedto help determine where, how, how far, or the like to stretch acompression garment 12 during application to get a proper therapeuticeffect. For instance, using a 25% overlap of a compression garment 12onto itself, after proper trimming and application, may allow thecompression garment 12 to work properly to prevent any exacerbation ofthe edema.

Fiducials 16 c and other markings 16 may be used to identify locationson a compression garment 12 where padding (e.g., spacer fabric, foam,foam with adhesive backing, or the like) may be added. Alternatively, orin addition thereto, the markings 16 may communicate a suitable orpreferred size or geometry of the padding. For example, the markings 16may communicate a location and desired channel shape for padding locatedproximate the back of the knee to facilitate lymph drainage, increasecomfort, or the like.

In selected embodiments, fiducials 16 c and other markings 16 mayidentify more than just locations where a compression garment 12 may beshortened or otherwise trimmed. For example, markings 16 may identifyone or more locations where small slits (e.g., slits about onecentimeter in length) may be formed in the compression fabric of acorresponding compression garment 12. Such slits acting alone or in adesired arrangement or pattern may permit greater stretching of acompression fabric, alter compression characteristics of compressiongarment 12, or the like.

Fiducials 16 c and other markings 16 on a template 14 may be transferredto a compression garment 12 to illustrate or communicate propercompression levels once the garment 12 is applied. By buildingcomplicated algorithms and processes into a template 14, a user ortrimmer of a compression garment 12 in accordance with the presentinvention may avoid such complexities.

Referring to FIG. 9, after taking and recording various measurements onthe worksheet 30 a of FIG. 5, a user may be ready to trim a compressiongarment 12 for an arm. Accordingly, a user overlay or otherwise alignthe compression garment 12 with an appropriate template 14. Using thetemplate 12, a user may trim a distal end 58 of the compression garment12 according to a measured distance “C to E” identified on the worksheet30 a. A user may trim a proximal end 60 of the compression garment 12according to a measured distance “E to G” identified on the worksheet 30a.

Once the distal and proximal ends 58, 60 are trimmed, a template 14 mayassist a user in identifying various lines (e.g., edges 16 c, dividinglines 16 d, or the like) corresponding to the worksheet 30 a. In theembodiment of FIG. 9, the distal edge of the compression garment 12 mayform or define line “C,” while the proximal edge of the compressiongarment 12 may form or define line “G.” Intermediate lines “D,” “E,” and“F” may be positioned as noted on the template 14.

Using the measurements recorded on the worksheet 30 a and the hash marks16 e of the template 14, a user may identify appropriate locations onthe various lines C, D, E, and F. In trimming the compression garment12, a user may “connect the dots,” crossing each of the various lines C,D, E, and F at the appropriate locations. A user may then follow one ormore dividing lines 16 d and cut therealong some distance (e.g., aboutthree or four centimeters) into the body or interior of the compressiongarment 12. The compression garment 12 may then be ready for donning bya patient. Since the compression garment 12 has been customized usingmeasurements collected directly from the patient, providing a specificoverlap distance as the compression garment 12 is wrapped around a limb(e.g., the patient's arm) may ensure that a desired or prescribedcompression is applied to the limb.

Referring to FIG. 10, in selected embodiments, a manufacturedcompression garment 12 may not easily lay flat. For example, assumingthat the template 14 shown in FIG. 10 were the fabric of a compressiongarment 12, a manufacturing process may connect (e.g., sew) a first edge62 to a corresponding second edge 64 to form a heel cup. So connected,the resulting compression garment 12 may not easily lay flat forapplication of a template 14 thereto.

In such embodiments, a partial template 14 may be used. A partialtemplate 14 may cover only those portions of the compression garment 12that need to be trimmed, that lay flat, or some combination thereof. Inthe illustrated embodiment, a partial template 14 may be formed byomitting certain portions of the template 14 (e.g., portions to theright of the illustrated line 66). Alternatively, a user may simplyfocus on properly overlaying a template 14 on certain of the portions ofa compression garment 12 that need to be trimmed. Thus, a user need nothave complete alignment at all times of all portions of a template 14with a corresponding compression garment 12.

After taking and recording various measurements noted on the footportion of worksheet 30 c of FIG. 7, a user may be ready to trim acompression garment 12 for a foot. Accordingly, a user may align (e.g.,partially overlay) the compression garment 12 with an appropriatetemplate 14. Using the template 14, a user may trim a third edge 68 ofthe compression garment 12 according to a measured distance “X”identified on the worksheet 30 c. A user may then trim fourth and fifthedges 70, 72 according to a measured circumference “A′” identified onthe worksheet 30 c. The location of the trimmed third edge 68 maydetermine where (e.g., at what value) corresponding measurements for thefourth and fifth edges 70, 72 begin.

Once the third, fourth, and fifth edges 68, 70, 72 are properly trimmed,the compression garment 12 may be ready for donning by a patient. Again,since the compression garment 12 has been customized using measurementscollected directly from a patient, providing a specific overlap distanceas the compression garment 12 is wrapped around a limb (e.g., thepatient's foot) may ensure that a desired or prescribed compression isapplied to the limb.

Referring to FIGS. 13 and 14, in selected embodiments, a template 14 mayinclude multiple sets of markings 16. For example, a first set ofmarkings 16 may correspond to a first compression level or profile,while a second set of markings 16 may correspond to a second compressionlevel or profile. The various sets of markings 16 may bedistinguishable. For example, a first set of markings 16 may be in afirst color, while a second set of markings 16 may be in a second,different color.

Alternatively, each template 14 may include only one set of markings 16.For example, a first template 14 may contain a set of markings 16corresponding to a first compression level or profile, while a secondtemplate 14 may contain a set of markings 16 corresponding to a secondcompression level or profile. In the illustrated embodiments, themarkings 16 on the template 14 of FIG. 14 are closer to the center 74 orinterior 74 of the template 14 than the markings on the template 14 ofFIG. 13. Accordingly, for a given patient, compression garment 12, andsecurement overlap, the template 14 of FIG. 14 may produce a garment 12exhibiting greater compression than the template 14 of FIG. 13.

The fabrics, substrates, materials, or the like used to form acompression garment 12 may vary between embodiments. In selectedembodiments, compression material used in a compression garment 12 maybe a short-stretch fabric with maximum elastic elongation of about 15%to about 100% of an unstretched length. As the short stretch materialnears its elastic limit, it may exhibit a fairly abrupt end-stretch orlock-out. The compression material may alternatively be a medium stretchor non-elastic fabric. In other embodiments, compression material usedin a compression garment 12 may be “non-elastic” fabric having have lessthan about 15% maximal elastic stretch or no stretch at all.

Compression material used in a compression garment 12 may be anon-woven, woven, knitted, spacer-fabric, or a combination of fabricwith lamination. The compression material may be a fabric laminated tofoam, polyurethane, another fabric, or a combination of non-woven andwoven or knitted fabrics. In certain embodiments, the compressionmaterial may be constructed by laminating two fabrics using foam orpolyurethane coating between the layers, or other lamination techniquesas known in the art. The compression garment may contain multiple fabrictypes, with various levels of maximum elastic stretch, variouscompression levels, or combinations thereof for any given fabricelongation.

The compression fabric may be selected based on a patient's measurementsor measurement range, a desired therapeutic compression, or the like.The compression fabric may be reusable, somewhat reusable, ordisposable. For example, compression fabric may comprise a disposablematerial designed for single use (e.g., nonwoven diaper-like material,nonwoven elastic bandage compression material, disposable multiple layercompression bandage material, or the like). Selected nonwoven materialssuitable for use in embodiments in accordance with the present inventionmay include polyester fabric containing longitudinal strands ofpolyester urethane or similar elastomeric fibers. Such polyester fabricmay be coated with a cohesive or adhesive substance. Alternatively, orin addition thereto, such fabrics may be compatible with hook-and-looptype fasteners (e.g., engage hook material urged thereagainst).

Embodiments in accordance with the present invention may include aseries of templates 14. An appropriate template 14 may be selected basedon the limb involved (e.g., foot, hand, leg, arm, abdomen, or the like),limb measurements (e.g., limb length, height, circumference, or thelike), limb size (e.g., XS, S, M, L, XL, XXL), limb geometry or shape,desired compression levels, desired fabric stretch once a garment 12donned, or the like. The chosen template 14 may be paired with a chosenor corresponding compression garment 12. The compression garment 12 maybe selected based on the nature of the limb involved, limb geometry orshape, desired compression level, degree of fabric stretch, color,texture, or the like. The chosen template 14 may then be used with thechosen compression garment 12 and the patient measurements to trim thecompression garment 12 in order to fit the patient. The trimmed garment12 may then be applied to the patient and provide therapeuticcompression.

A template 14 may be disposable or re-usable and constructed of paper,plastic, metal, cardboard, foamboard, or the like. A template 14 mayhave similar stretch to a corresponding compression fabric, so that itcan be properly proven on the limb or body section prior to trimming theactual material of a compression garment 12. A template 14 mayalternatively comprise an electronic file. For example, a template 14may be a image generated by an electronic file and projected onto acompression garment 12.

In selected embodiments, a selection may be made based on desiredfeatures of a corresponding compression garment 12 (e.g., limb at issue,limb, size, closed toe, open toe, wide band at top, desired compressionlevels, etc.). A user may then collect various measurements from apatient (e.g., himself or herself) and enter them into a computerprogram (e.g., a program accessed over the Internet). A computer programmay then generate an intermediate template 14 that may be printed orprojected onto a template substrate (e.g., material used to form a finalor usable template 14). When completed, the template 14 (e.g., the finalor usable template 14) may be used to trim a corresponding compressiongarment 12. Alternatively, a computer program may generate a template 14that may be printed or projected directly onto a correspondingcompression garment 12 to assist in proper trimming of the garment 12.

In view of the foregoing, a therapeutic compression apparatus maycomprise (1) a compression garment wrappable circumferentially about alimb of a patient and (2) at least one template comprising markingsshowing where to trim the compression garment to enable the compressiongarment to deliver a particular therapeutic compression profile to thelimb. The at least one template may comprise a shape matching thecompression garment.

The matching shape may enable a user to align the at least one templatewith respect to the compression garment. For example, the compressiongarment may comprise a garment perimeter. The at least one template maycomprise a first template having a template perimeter. The templateperimeter may match the entire garment perimeter. Alternatively, thetemplate perimeter may match a portion of the garment perimeter, whereinthe portion is sufficient to definitely and uniquely align the firsttemplate with respect to the compression garment. The at least onetemplate may comprise paper with the markings printed thereon.

A first template of the at least one template may comprise markingsenabling customization of the compression garment to deliver a firstcompression profile. A second template of the at least one template maycomprise markings enabling customization of the compression garment todeliver a second compression profile, distinct from the firstcompression profile. A third template of the at least one template maycomprise markings enabling customization of the compression garment todeliver a third compression profile, distinct from both the first andsecond compression profiles.

The compression garment may further comprise one or more bandspositioned to wrap circumferentially about the limb of the patient. Themarkings may identify locations for trimming the one or more bands toshorten a circumferential reach thereof. The markings may provide acompressed scale taking into account the degree of stretch atapplication of the compression garment. The markings may include aplurality of numbers and a plurality of trim lines. Each number of theplurality of numbers may be positioned adjacent a corresponding trimline of the plurality of trim lines. The numbers may corresponding tomeasurements collected from the limb.

The compression garment of the therapeutic compression apparatuspresented above may comprise short stretch material having a maximumelasticity of 15 to 100 percent under reasonable tensile loads.Reasonable tensile loads may be applied to a particular band of thecompression garment and have a magnitude between about 2 lbs and about20 lbs.

The therapeutic compression apparatus presented above may furthercomprise instructions instructing how to custom fit the compressiongarment to the patient, the instructions comprising (1) a firstinstruction to obtain a measurement of the circumference of the limb ata point and (2) a second instruction to cut the compression garment at amarking of the markings corresponding to the measurement.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrative,and not restrictive. The scope of the invention is, therefore, indicatedby the appended claims, rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

What is claimed and desired to be secured by United States LettersPatent is:
 1. A method of treating a condition of a patient's limb, themethod comprising: obtaining a compression garment comprising a sheet ofmaterial wrappable about a limb of a patient, a first plurality ofmarkings corresponding to the sheet, a second plurality of markingscorresponding to the sheet, the first plurality of markings, whereineach marking thereof comprises a number and shows where to cut the sheetto deliver, for a given overlap of the sheet upon itself, a firstparticular compression to a portion of the limb having a circumferencecorresponding to the number, and the first plurality of markings,wherein the it particular compression for each of the first plurality ofmarkings is in a first range selected from the group consisting of 8-15mmHg, 15-20 mmHg, 20-30 mmHg, 30-40 mmHg, and 40-50 mmHg, the secondplurality of markings, wherein each marking thereof comprises a numberand shows where to cut the sheet to deliver, for the given overlap ofthe sheet upon itself, a second particular compression to a portion of alimb having a circumference corresponding to the number; and the secondplurality of markings, wherein the second particular compression foreach of the second plurality of markings is in a second range, distinctfrom the first range, selected from the group consisting of 8-15 mmHg,15-20 mmHg, 20-30 mmHg, 30-40 mmHg, and 40-50 mmHg; taking a measurementof a circumference of the limb; and cutting the compression garmentalong a marking of one of the first plurality of markings and the secondplurality of markings that matches the measurement.
 2. The method ofclaim 1, wherein the material comprises short stretch material having anappreciable end stretch after an elongation in the range of 15 to 100percent.
 3. The method of claim 1, wherein the compression garmentcomprises non-elastic material, short stretch material, moderate stretchmaterial, or long stretch material.
 4. The method of claim 1, furthercomprising donning, by the patient after the cutting, the compressiongarment.
 5. The method of claim 4, further comprising providing, by thecompression garment after the donning, therapeutic compression to thelimb.
 6. The method of claim 4, wherein the donning comprises applyingat least a portion of the compression garment at substantially endstretch.
 7. The method of claim 1, wherein at least one of the first andsecond plurality of markings is on a template.
 8. The method of claim 1,further comprising overlaying, prior to the cutting, at least a portionof the compression garment with the template.
 9. The method of claim 1,wherein the compression garment further comprises: an upper band; lowerbands; and an attachment mechanism attaching the upper band to the lowerbands.
 10. The method of claim 9, further comprising cutting away, priorto the donning, the upper band by trimming the attachment mechanism. 11.A therapeutic compression garment system comprising: a sheet of materialwrappable about a limb; a first plurality of markings corresponding tothe sheet; a second plurality of markings corresponding to the sheet;the first plurality of markings, wherein each marking thereof comprisesa number and shows where to cut the sheet to deliver, for a givenoverlap of the sheet upon itself, a first particular compression to aportion of the limb having a circumference corresponding to the number;the first plurality of markings, wherein the first particularcompression for each of the first plurality of markings is in a firstrange selected from the group consisting of 8-15 mmHg, 15-20 mmHg, 20-30mmHg, 30-40 mmHg, and 40-50 mmHg; the second plurality of markings,wherein each marking thereof comprises a number and shows where to cutthe sheet to deliver, for the given overlap of the sheet upon itself, asecond particular compression to a portion of a limb having acircumference corresponding to the number; and the second plurality ofmarkings, wherein the second particular compression for each of thesecond plurality of markings is in a second range, distinct from thefirst range, selected from the group consisting of 8-15 mmHg, 15-20mmHg, 20-30 mmHg, 30-40 mmHg, and 40-50 mmHg.
 12. The system of claim11, wherein the material is short stretch material having an appreciableend stretch after an elongation in the range of 15 to 100 percent. 13.The system of claim 11, wherein the material is non-elastic material,short stretch material, moderate stretch material, or long stretchmaterial.
 14. The system of claim 11, wherein at least one of the firstand second plurality of markings is on the material.
 15. The system ofclaim 11, wherein at least one of the first and second plurality ofmarkings is on a template.
 16. The system of claim 15, furthercomprising overlaying, prior to the cutting, at least a portion of thecompression garment with the template.
 17. A method of treating acondition of a patient's limb, the method comprising: receiving, at asite, a patient suffering from at least one of lymphedema and venousinsufficiency; obtaining, at the site, a compression garment comprisinga sheet of material wrappable about a limb of the patient, a firstplurality of markings corresponding to the sheet, a second plurality ofmarkings corresponding to the sheet, the first plurality of markings,wherein each marking thereof comprises a number and shows where to cutthe sheet to deliver, for a given overlap of the sheet upon itself, afirst particular compression to a portion of the limb having acircumference corresponding to the number, and the first plurality ofmarkings, wherein the first particular compression for each of the firstplurality of markings is in a first range selected from the groupconsisting of 8-15 mmHg, 15-20 mmHg, 20-30 mmHg, 30-40 mmHg, and 40-50mmHg, the second plurality of markings, wherein each marking thereofcomprises a number and shows where to cut the sheet to deliver, for thegiven overlap of the sheet upon itself, a second particular compressionto a portion of a limb having a circumference corresponding to thenumber; and the second plurality of markings, wherein the secondparticular compression for each of the second plurality of markings isin a second range, distinct from the first range, selected from thegroup consisting of 8-15 mmHg, 15-20 mmHg, 20-30 mmHg, 30-40 mmHg, and40-50 mmHg; taking, at the site, a measurement of a circumference of thelimb; and cutting, at the site, the compression garment along a markingof one of the first plurality of markings and the second plurality ofmarkings that matches the measurement.
 18. The method of claim 17,wherein the obtaining comprises obtaining the compression garmentfurther comprising an attachment mechanism.
 19. The method of claim 17,further comprising, donning by the patient at the site, the compressiongarment by wrapping the sheet around the limb and using the attachmentmechanism to maintain the sheet wrapped around the limb.
 20. The methodof claim 17, wherein the site is a hospital, medical clinic, or place ofbusiness of a supplier or distributor of durable medial equipment.